Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Novocure enrolls 1st patient in phase III brain metastases trial
Novocure said that the 1st patient has been enrolled in a Phase III pivotal trial of its tumor-treating field technology in combination with radiosurgery to treat brain metastases from non-small-cell lung cancer.
The St. Helier, N.J.-based company’s tumor treating fields (TTFields) are low-intensity, intermediate-frequency, alternating electric fields designed to disrupt cell division within cancer cells. Novocure’s commercial product, Optune, is indicated in the U.S. as a therapy in combination with temozolomide to treat gliobastoma. Read more
4. FDA inks deal with CluePoints to use data to sniff out sloppy or fraudulent clinical trials
The FDA said today it inked a cooperative research and development agreement with statistical monitoring company CluePoints to identify clinical trial sites that don’t meet the agency’s standards.
The CluePoints platform is designed to use “statistical algorithms to determine the quality, accuracy and integrity of clinical trial data during and after studies are conducted,” the company said. Read more
3. Fortimedix Surgical raises $12m for single-port surgery device
Fortimedix Surgical said today that it raised a $12 million Series A round it plans to use to commercialize its newly approved device for single-port laparoscopic surgeries.
The round, which brought in €11 million for Fortimedix’s FMX314 device, was led by Dutch VC shop Chemelot Ventures. All existing investors also participated, the company said, noting that it laned more cash from MKB Leningenfonds and Rijksdienst voor Ondernemend Nederland of the Dutch Economic Affairs Ministry. Read more
2. Medical devices a factor in Minnesota Congressional races
The medical device industry is a major factor in a pair of Congressional races in Minnesota, as a former medtech executive squares off against a onetime right-wing talk show host and an incumbent with strong ties to the sector looks to hold on to his seat.
Rep. Erik Paulsen (R), a longtime Washington champion for medtech who spearheaded the successful campaign to stall the medical device tax, is running for re-election for Minnesota’s 3rd District. He’s running against state Sen. Terri Bonoff (D) and, although he’s largely considered the favorite (Paulsen took the district by 25 points in 2014), a backlash at the polls against Republican presidential candidate Donald Trump could threaten his chances. Read more
1. St. Jude Medical is only the latest medical device maker to face battery issues
The battery depletion issue confronting St. Jude Medical this week is only the latest such issue to bedevil a medical device maker, as its arch-rivals in the cardiac rhythm management space have issued their own recalls in recent years.
St. Jude yesterday warned of the possibility that a battery issue could disable its high-voltage cardiac rhythm management devices, saying the problem is associated with 2 deaths among the nearly 400,000 patients implanted with affected devices. The news sent STJ shares down -3.5% to $78.41 apiece yesterday and the stock was down another -0.1% to $78.30 today in mid-morning trading – partially erasing its recovery from a short-seller’s allegation of cybersecurity vulnerabilities with its Merlin@home remote monitoring system. Read more